A Study of LY4065967 in Healthy Japanese Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY4065967; Drug: Placebo; Drug: Rosuvastatin

• Registration Number: NCT06594159
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to obtain safety and tolerability data of the study drug known as LY4065967 and rosuvastatin in healthy Japanese participants. Blood tests will be performed to check how much LY4065967 and rosuvastatin get into the bloodstream and how long it takes the body to eliminate it. This is a 3-part study and will last approximately 2 weeks excluding screening period for each part.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Study Start: 2024-10-22
• Status Verified: 2025-03
• Primary Completion: 2025-03-11
• Study Completion: 2025-03-11
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Japanese participants who are overtly healthy as determined by medical evaluation including medical history and physical examination
• Have a body mass index within the range 18 to 30 kilogram per square meter (kg/m2)
• Have a body weight of:
• ≥ 40 kilograms (kg) for individuals assigned female at birth
• ≥ 50 kg for individuals assigned male at birth

Exclusion Criteria

• Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or convulsions that, in the judgment of the investigator, indicate a medical problem that would preclude study participation
• Have an abnormality in the 12-lead echocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have a history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions, which in the opinion of the investigator may hamper participation in the study
• Show evidence of hepatitis C and/or have a positive hepatitis C virus antibody test
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antigen and/or antibodies.
• Show evidence of hepatitis B and/or positive hepatitis B surface antigen
• Show evidence of syphilis or have a positive syphilis test.
• Have an abnormal blood pressure (supine) as determined by the investigator
• Are pregnant or intend to become pregnant or to breastfeed during the study.
• Participants with a history of drug abuse which, in the opinion of the investigator, is clinically significant or who test positive for drugs of abuse at screening or admission
• Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator
• Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes
• Are unwilling to comply with the dietary restrictions required for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY4065967 Part B	LY4065967	Multiple doses of LY4065967 administered orally
LY4065967 Part A	LY4065967	A single dose of LY4065967 administered orally
Placebo Part A	Placebo	Placebo administered orally
LY4065967 and Rosuvastatin Part D	Rosuvastatin	LY4065967 and Rosuvastatin administered orally
Placebo Part B	Placebo	Placebo administered orally
LY4065967 and Rosuvastatin Part D	LY4065967	LY4065967 and Rosuvastatin administered orally

Primary Outcome Measures

Name	Time	Method
Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin	Predose on Day 1 Through 72 Hours Post-Dose	Part D: PK: Cmax of Rosuvastatin
Part A: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration	Baseline to 7 Days	Part A: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Part B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration	Baseline to 12 Days	Part B: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of Rosuvastatin	Predose on Day 1 Through 72 Hours Post-Dose	Part D: PK: AUC of Rosuvastatin

Secondary Outcome Measures

Name	Time	Method
Part A : Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967	Predose on Day 1 Through 48 Hours Post-Dose	Part A: PK: Cmax of LY4065967
Part B: PK: Cmax of LY4065967	Predose on Day 1 Through Day 9	Part B: PK: Cmax of LY4065967
Part A and B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967	Predose on Day 1 Through 48 Hours Post-Dose	Part A and B: PK: AUC of LY4065967
Part D: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967	Day 5 Through Day 11	Part D: PK: Cmax of LY4065967
Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967	Day 5 Through Day 11	Part D: PK: AUC of LY4065967

Trial Locations

Locations (1)

Souseikai Fukuoka Mirai Hospital; 🇯🇵 Fukuoka, Japan